Mental HealthNCT04608578
Evaluation of a Serious Game Aimed at Improving Mental Health in Youth.
A study testing Silver in people with Mental Health, run by University Ghent at 14 sites in Belgium.
Trial summary
The main goal of this study is to evaluate the effectiveness of a serious game aimed at improving mental health in teenagers aged 12-16 years old. This will test the effectiveness by studying the effect on emotion regulation strategies, coping strategies, the presence of cognitive errors and suicidal ideation. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Silver
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 14 sitesBelgium
- Study dates
- 26 Oct 2020to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Dutch speaking
- having access to a smartphone or tablet
Who cannot join
- not being part of the selected classes in the participating schools
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Belgium14 sites
De!Kunsthumaniora
Antwerp
KA Beveren
Beveren
VTI Brugge
Bruges
GO! Atheneum Denderleeuw
Denderleeuw
Kunsthumaniora Sint-Lucas
Ghent
Humaniora Kindsheid Jesu
Hasselt
Middenschool Kindsheid Jesu
Hasselt
GO! Atheneum Heist
Heist-op-den-Berg
RHIZO Hotelschool
Kortrijk
RHIZO Lyceum OLV Vlaanderen
Kortrijk
GO! Campus Redingenhof Leuven
Leuven
GO! Atheneum Ninove
Ninove
De Burgerschool
Roeselare
PITO Stabroek
Stabroek
About this study
The main goal of this study is to evaluate the effectiveness of a serious game aimed at improving mental health in teenagers aged 12-16 years old. This will test the effectiveness by studying the effect on emotion regulation strategies, coping strategies, the presence of cognitive errors and suicidal ideation. Participants will also be asked to evaluate the game. The study is a cluster-randomized controlled trial conducted in secondary schools in Flanders.
- Conditions
- Mental Health
- Being tested
- Silver
- Keywords
- Suicide Prevention, Universal Suicide Prevention, Serious Game
- Medical subject headings
- Psychological Well-Being, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilverBehavioural
A serious game to improve mental health in youth
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group gain access to the game after filling in the baseline online questionnaire. The participants are asked to play at least two characters in the game. They have two weeks to play the game. Receives: Behavioral: Silver |
| Control group | No intervention | Waitlist control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dutch version of the Questionnaire for the assessment of emotion regulation in children and adolescents (FEEL-KJ)
A 90-item self-report instrument measuring seven adaptive, five maladaptive, and three external emotion (sadness, anger, and anxiety) regulation strategies. Each item is rated on a 5-point Likert scale from 1 = almost never to 5 = almost always. The score on the adaptive (ranging from 42-210), maladaptive (ranging from 30-150) and external (ranging from 18-90) subscales are considered. The higher the score on a subscale, the greater the disposition to cope with negative emotions in a certain way.
Measured: Baseline and posttest (after 2 weeks)
Secondary outcomes (4)
Children's Coping Strategies Checklist -Revision 1 (CCSC-R1)
3 subscales on cognitive coping strategies (i.e., optimism, control, and seeking understanding) are used. Each subscale has 4 items and all items are scored on a 4-point Likert scale from 1 = never to 4 = most of the time. For each subscale the minimum total score is 4 and the maximum score 16. The higher the mean score on the subscale, the more often the cognitive coping strategy is used.
Measured: Baseline and posttest (after 2 weeks)
Children's Negative Cognitive Error Questionnaire-Revised (CNCEQ-R)
The scale assess cognitive Errors and has 5 subscales and 16 items in total. The items are rated on a 5-point Likert scale from 1 = not at all like I would think to 5 = almost exactly like I would think. Total scores range from 16-80. Higher scores reflect more distorted cognitive processes.
Measured: Baseline and posttest (after 2 weeks)
2 subscales of the EMO-check kids
Two subscales of the EMO-Check kids are used i.e., Emotional clearness and Understanding emotions. They measure strategies to cope with emotions on a 5-point Likert scale from 0 = not at all to 4 = (almost) always. The score on a subscale ranges from 0 to 12. Higher score indicate more use a certain emotion regulation strategy.
Measured: Baseline and posttest (after 2 weeks)
Children's Depression Inventory, version 2 (CDI-2)
A 28-item self-report scale measuring depressive symptoms experienced over the previous 2 weeks. Items are score on a scale from 0 to 2. Total scores range from 0 to 56. Higher scores indicate greater severity of depressive symptomatology.
Measured: Baseline and posttest (after 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start26 Oct 2020
- Primary completion31 Dec 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Portzky, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608578
- Sponsor's protocol ID
- BC - 07288
- Status last verified
- Dec 2021
- First submitted
- 24 Oct 2020
- Last updated
- 10 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Serious Game Aimed at Improving Mental Health in Youth.
- ClinicalTrials.gov ID
- NCT04608578
- Acronym / sponsor ID
- BC - 07288
- Conditions
- Mental Health
- Keywords
- Suicide Prevention, Universal Suicide Prevention, Serious Game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to evaluate the effectiveness of a serious game aimed at improving mental health in teenagers aged 12-16 years old. This will test the effectiveness by studying the effect on emotion regulation strategies, coping strategies, the presence of cognitive errors and suicidal ideation. Participants will also be asked to evaluate the game. The study is a cluster-randomized controlled trial conducted in secondary schools in Flanders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: SilverThe intervention group gain access to the game after filling in the baseline online questionnaire. The participants are asked to play at least two characters in the game. They have two weeks to play the game. |
| Control group | No intervention | –Waitlist control group |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Dutch speaking
- having access to a smartphone or tablet
Key exclusion criteria (1 listed)
- not being part of the selected classes in the participating schools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilverA serious game to improve mental health in youth | Behavioural | Intervention group |
Primary outcome
The Dutch version of the Questionnaire for the assessment of emotion regulation in children and adolescents (FEEL-KJ)
Time frame: Baseline and posttest (after 2 weeks)
A 90-item self-report instrument measuring seven adaptive, five maladaptive, and three external emotion (sadness, anger, and anxiety) regulation strategies. Each item is rated on a 5-point Likert scale from 1 = almost never to 5 = almost always. The score on the adaptive (ranging from 42-210), maladaptive (ranging from 30-150) and external (ranging from 18-90) subscales are considered. The higher the score on a subscale, the greater the disposition to cope with negative emotions in a certain way.
4 secondary outcomes
Children's Coping Strategies Checklist -Revision 1 (CCSC-R1)
Time frame: Baseline and posttest (after 2 weeks)
Children's Negative Cognitive Error Questionnaire-Revised (CNCEQ-R)
Time frame: Baseline and posttest (after 2 weeks)
2 subscales of the EMO-check kids
Time frame: Baseline and posttest (after 2 weeks)
Children's Depression Inventory, version 2 (CDI-2)
Time frame: Baseline and posttest (after 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwendolyn Portzky, PhD principal investigator
University Ghent
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver in people with Mental Health, run by University Ghent at 14 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Dutch version of the Questionnaire for the assessment of emotion regulation in children and adolescents (FEEL-KJ) (time frame: Baseline and posttest (after 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.